510(k) Premarket Notification

• Device Classification Name: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
• 510(k) Number: K080979
• Device Name: STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
• Applicant: Biomet Manufacturing Corp; P.O. Box 587; Warsaw, IN 46581 -0587
• Applicant Contact: GARY BAKER
• Correspondent: Biomet Manufacturing Corp; P.O. Box 587; Warsaw, IN 46581 -0587
• Correspondent Contact: GARY BAKER
• Regulation Number: 888.3390
• Classification Product Code: KWY
• Subsequent Product Code: KWL
• Date Received: 04/07/2008
• Decision Date: 10/31/2008
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Orthopedic
• 510k Review Panel: Orthopedic
• Summary: Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH Recalls